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Recruiting NCT06330142

Hippotherapy Teenager-pediatric Radiotherapy

No phase Interventional Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Participation in 10 horse-assisted therapy sessions.
Who it may be relevant to
Registry conditions: Radiotherapy. Basic parameters: 8 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

T-QAP: radioTherapy eQuicie Adolescent - Pediatrics

Overview

This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department. The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion.

Detailed description

Electro-radiology medical technician (ERMT) are privileged contacts with children. They accompany them every day during radiotherapy sessions. An animal-mediated approach would provide a new out-of-hospital environment. The equine sessions, precious moments when the child can forget about his illness, would enable him to escape from his condition as a patient. Indeed, the sick child adopts a posture to withstand treatment and take on responsibilities such as "not crying" and "being brave". These moments, away from the hospital, are essential to the smooth running of care, since they limit the weariness induced by daily radiotherapy sessions and help preserve the quality of caregiver/child cooperation during treatment.

Interventions

  • Other Participation in 10 horse-assisted therapy sessions
    supporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach

Primary outcome measures

  • Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy [Time frame: before radiotherapy, halfway through the HAT sessions (at 5 weeks), at the end of the HAT sessions (at 10 weeks) and one month after the end of the HAT sessions]
Secondary outcome measures (10)
  • Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT [Time frame: before radiotherapy, halfway through the HAT sessions (at 5 weeks), at the end of the HAT sessions (at 10 weeks) and one month after the end of the HAT sessions]
  • Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT [Time frame: before radiotherapy, halfway through HAT sessions (at 5 weeks), at the end of HAT sessions (at 10 weeks) and one month after the end of HAT sessions]
  • Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT [Time frame: before radiotherapy, halfway through HAT sessions (at 5 weeks), at the end of HAT sessions (at 10 weeks) and one month after the end of HAT sessions]
  • Assessing the acute side effects of radiotherapy at the start and end of irradiation [Time frame: at the start and end of radiotherapy sessions (from 3 to 7 weeks)]
  • Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse [Time frame: At every HAT sessions (up to 10 weeks)]
  • Evaluate participant's expectations and satisfaction with their care [Time frame: at the beginning and end of HAT sessions (up to 10 weeks)]
  • Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation [Time frame: every week during radiotherapy (from 3 to 7 weeks)]
  • Assessing the impact of HAT on the child during irradiation according to the MERT [Time frame: at each radiotherapy session (from 3 to 7 weeks)]
  • Evaluate the rider's impression of the child's well-being of the child during HAT sessions [Time frame: at the end of the first session and at the end of the last session of HAT (up to 10 weeks)]
  • Assessing the impact of an alternative activity on parents' satisfaction with care [Time frame: at the end of the HAT sessions (at 10 weeks)]

Eligibility criteria

Inclusion criteria

  • Children aged 8 to <18 years.
  • With an indication for radiotherapy for cancer (of any type)
  • Patients hospitalized and/or managed on an ambulatory basis
  • WHO ≤ 2
  • Child and parents (or accompanying adults) who speak and understand French
  • Free, express and informed consent of the adult patient OR of those exercising parental authority for minor patients
  • Child with social security coverage

Exclusion criteria

  • Children afraid of horses and stables
  • Contraindication to the practice of equine-assisted therapy (allergy to horses or dust, children with asthma attacks triggered by dust/animal hair ...)
  • Patient on stretcher
  • Children or parents (or carers) with significant cognitive impairment, making self-assessment or hetero-assessment impossible even with assistance
  • Unavailability or lack of interest in participating in equine-assisted therapy sessions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre Paul Strauss — Strasbourg

Identifiers

NCT: NCT06330142 · 2022-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗